FDA UDI
In Commercial Distribution
🇺🇸 United States
Mor-Medical New Era
DI: 00850010988764
·
Model: DNE-SG10
·
Moroles Investments, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mor-Medical New Era
- Primary DI
- 00850010988764
- Version / Model
- DNE-SG10
- Company Name
- Moroles Investments, LLC
- Labeler DUNS
- 045103307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-17
- Public Version
- 1
- Public Version Date
- 2024-07-25
- Public Version Status
- New
- Public Device Record Key
- c7ec5d4d-90cf-443d-b8cd-23fa0906c8cf
Device Description
Deluxe New Era Patented Infection Control Soft Touch Shower Gurney with Elevated Head Section, 450 lbs. wt. capacity
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPO | Stretcher, Wheeled | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31092 | Bathing stretcher | A manually-operated device consisting of a platform mounted on a frame designed to support a recumbent patient for bathing. It is designed to be submerged in an appropriate bath. The device is used primarily for a patient incapable of supporting themself in an upright position for bathing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010988764 | GS1 |